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This
article defines coding and coverage for Ifosfamide
including off-label indications. National Government Services Local
Coverage Determination (LCD) “Coverage of Drugs and Biologicals
for Label and Off-Label Uses” allows coverage for off-label indications
only if the United States Pharmacopeia Drug Information (USP-DI), the
American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such
indications or if National Government Services has published an article or
LCD expanding such coverage. Providers may request approval for additional
off-label indications by submitting this request in writing with supporting
medical literature. The aforementioned National Government Services LCD,
which describes the requirements for such a request, can be accessed on our
contractor Web site at www.NGSMedicare.com or on the Medicare Coverage
Database at www.cms.hhs.gov/mcd.
Abstract:
Ifosfamide is classified as an alkylating agent of the nitrogen mustard type. Because
of the risk of hemorrhagic cystitis, Ifosfamide
is generally administered in combination with a prophylactic agent, such as
mesna.
Indications:
Ifosfamide, in combination
with certain other approved antineoplastic
agents, is approved for germ cell testicular cancer.
Medicare will cover Ifosfamide for the treatment
of the following indications:
• Head and neck carcinoma
• Soft-tissue sarcomas
• Ewing’s sarcoma
• Hodgkin’s lymphoma
• Non-Hodgkin’s lymphoma
• Breast carcinoma
• Cervical carcinoma
• Small cell carcinoma of the lung
• Non-small cell carcinoma of the lung
• Ovarian epithelial carcinoma
• Acute lymphocytic leukemia
• Neuroblastoma
• Osteosarcoma
• Germ cell ovarian tumors (in combination with other agents)
• Bladder carcinoma (alone and in combination with other agents)
• Endometrial carcinoma
• Relapsed or refractory thymoma and thymic carcinoma
• Wilms’ tumor (alone or in combination with
other agents, as second-line therapy for the treatment of Wilms’ tumor in patients who have not responded to or
whose disease has progressed during previous treatment)
• Uterine carcinoma
Indications expanded by this Article:
Pancreatic carcinoma
Utilization:
It is expected that these services would be performed as indicated by
current medical literature and/or standards of practice. When services are
performed in excess of established parameters, they may be subject to
review for medical necessity.
Documentation Requirements:
Medical record documentation maintained by the ordering/referring physician
must substantiate the medical need for the use of Ifosfamide
by clearly indicating the condition for which this drug is being used. This
might include the type of cancer, staging, if applicable, prior therapy and
the patient’s response to that therapy. This documentation is usually found
in the history and physical or in the office/progress notes.
If the provider of the service is other than the ordering/referring
physician, that provider must maintain copies of the ordering/referring
physician’s order for the chemotherapy drug. The physician must state the
clinical indication/medical need for using the chemotherapy drug in the
order.
Coding Guidelines:
For claims submitted to the carrier:
Ifosfamide should be billed using chemotherapy
administration codes and is payable in the following places of service:
office (11), skilled nursing home for patients in a Part A stay (31) [if
the drug is supplied by the facility, no claims for the drug should be
submitted to the Part B carrier.], nursing facility for patients not in a
Part A stay (32) and independent clinic (49) only when supplied as an
“incident to” service by the physician.
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